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Acute Coronary Syndrome Resource Center

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RC/azAcuteCoronarySyndromeRCheader.jpg" alt="Acute Coronary Syndrome Resource Center" border="0"/></a> <div class="az-sponsor-line">Sponsored by AstraZeneca<br/> This product information is intended for US healthcare professionals only. </div> <div class="az-sponsor_links"><a href="https://web.archive.org/web/20130807085005/http://www1.astrazeneca-us.com/pi/brilinta.pdf" target="_blank" rel="gaeventtracking;AstraZeneca Resource Center;Open Page;Top Prescribing Information">Prescribing Information</a> <a href="https://web.archive.org/web/20130807085005/http://www.brilintatouchpoints.com/clinical-pharmacology-video/#ISI" target="_blank" rel="gaeventtracking;AstraZeneca Resource Center;Open Page;Top Important Safety Information including Boxed warnings">Important Safety Information including Boxed WARNINGS</a> <a href="https://web.archive.org/web/20130807085005/http://brilintarems.com/" target="_blank" rel="gaeventtracking;AstraZeneca Resource Center;Open Page;Top BRILINTA REMS Information">BRILINTA REMS Information</a></div> <div class="AZ-Full-Disclaimer"> <p><strong>Welcome to the Healio.com Cardiology Acute Coronary Syndrome Resource Center</strong>, sponsored by AstraZeneca. This is your central portal for ACS information related to BRILINTA&reg; and clinical trial and guideline updates. Be sure to check back often for new videos, articles, and other featured content.</p> <p>BRILINTA (ticagrelor) is indicated to reduce the rate of thrombotic cardiovascular (CV) events in patients with acute coronary syndrome (ACS) (unstable angina, non&ndash;ST-elevation myocardial infarction, or ST-elevation myocardial infarction).&nbsp; BRILINTA has been shown to reduce the rate of a combined end point of CV death, myocardial infarction (MI), or stroke compared to clopidogrel. The difference between treatments was driven by CV death and MI with no difference in stroke.&nbsp; In patients treated with percutaneous coronary intervention (PCI), it also reduces the rate of stent thrombosis.</p> <p>BRILINTA has been studied in ACS in combination with aspirin. Maintenance doses of aspirin &gt;100 mg decreased the effectiveness of BRILINTA. Avoid maintenance doses of aspirin &gt;100 mg daily.</p> <h2>IMPORTANT SAFETY INFORMATION ABOUT BRILINTA<br/> <br/> WARNING: BLEEDING RISK</h2> <ul> <strong> <li><span>BRILINTA, like other antiplatelet agents, can cause significant, sometimes fatal, bleeding</span></li> <li><span>Do not use BRILINTA in patients with active pathological bleeding or a history of intracranial hemorrhage</span></li> <li><span>Do not start BRILINTA in patients planned to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue BRILINTA at least 5 days prior to any surgery</span></li> <li><span>Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgical procedures in the setting of BRILINTA</span></li> <li><span>If possible, manage bleeding without discontinuing BRILINTA. Stopping BRILINTA increases the risk of subsequent cardiovascular events</span></li> </strong></ul> <h2>WARNING: ASPIRIN DOSE AND BRILINTA EFFECTIVENESS</h2> <ul> <strong> <li><span>Maintenance doses of aspirin above 100 mg reduce the effectiveness of BRILINTA and should be avoided. After any initial dose, use with aspirin 75 mg - 100 mg per day</span></li> </strong></ul> <h2>CONTRAINDICATIONS</h2> <ul> <li><span>BRILINTA is contraindicated in patients with a history of intracranial hemorrhage and active pathological bleeding such as peptic ulcer or intracranial hemorrhage. BRILINTA is contraindicated in patients with severe hepatic impairment because of a probable increase in exposure; it has not been studied in these patients. Severe hepatic impairment increases the risk of bleeding because of reduced synthesis of coagulation proteins. BRILINTA is also contraindicated in patients with hypersensitivity (e.g. angioedema) to ticagrelor or any component of the product.</span></li> </ul> <p><strong>Please read accompanying full Prescribing Information, including Boxed WARNINGS, and Medication Guide.</strong></p> </div> <br/> <!-- silo content --> <div id="silo-content"> <!--<div class="module-box-video left az"> <ul class="az"> <li class="title">Video</li> <li class="az-body"><a href="/Presentation/Redirects/Error.aspx?item=web%3a%7bEA5744A7-6938-466E-9804-1A21B5E38BBA%7d%40en"><strong>Watch these and other related videos in the Acute Coronary Syndrome Resource Center</strong></a></li> <li class="img"><a href="/Presentation/Redirects/Error.aspx?item=web%3a%7bEA5744A7-6938-466E-9804-1A21B5E38BBA%7d%40en"><img alt="" src="/~/media/Images/Resource Centers/AZ ACS RC/azgenericvideoicon.jpg" /></a></li> <li class="video_title_first"><a href="/Presentation/Redirects/Error.aspx?item=web%3a%7bEA5744A7-6938-466E-9804-1A21B5E38BBA%7d%40en"><strong>Review of prescribing information for a medication option</strong></a></li> <li class="img"><a href="/Presentation/Redirects/Error.aspx?item=web%3a%7bEA5744A7-6938-466E-9804-1A21B5E38BBA%7d%40en"><img alt="" src="/~/media/Images/Resource Centers/AZ ACS RC/azgenericvideoicon.jpg" /></a></li> <li class="video_title_last"><a href="/Presentation/Redirects/Error.aspx?item=web%3a%7bEA5744A7-6938-466E-9804-1A21B5E38BBA%7d%40en"><strong>Review of mechanism of action for a medication option</strong></a></li> </ul> </div>--> <div class="module-box-generic left az"> <ul class="az"> <li class="title">Major Guidelines for Invasive and Noninvasive Management of Acute Coronary Syndrome (ACS)</li> <li><a href="/web/20130807085005/http://www.healio.com/cardiology/acute-coronary-syndrome-resource-center/major-guidelines" class="AZ-Full-Disclaimer">2012 ACCF/AHA guideline for managing patients with UA/NSTEMI invasively or noninvasively<span class="super">1</span></a></li> <li><a href="/web/20130807085005/http://www.healio.com/cardiology/acute-coronary-syndrome-resource-center/major-guidelines">2012 ESC guidelines for managing patients with STEMI<span class="super">2</span></a></li> <li><a href="/web/20130807085005/http://www.healio.com/cardiology/acute-coronary-syndrome-resource-center/major-guidelines">2012 ACCP guideline for antithrombotic therapy<span class="super">3</span></a></li> <li><a href="/web/20130807085005/http://www.healio.com/cardiology/acute-coronary-syndrome-resource-center/major-guidelines">2011 ACCF/AHA/SCAI guideline for PCI<span class="super">4</span></a></li> <li><a href="/web/20130807085005/http://www.healio.com/cardiology/acute-coronary-syndrome-resource-center/major-guidelines">2011 ACCF/AHA guideline for CABG<span class="super">5</span></a></li> </ul> <br> <ol> <li class="references">Jneid H, Anderson JL, Wright RS, et al. 2012 ACCF/AHA focused update of the guideline for the management of patients with unstable angina/non鈥揝T-elevation myocardialinfarction (updating the 2007 guideline and replacing the 2011 focused update): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines.&nbsp;<em>Circulation.</em>&nbsp;2012;126(7):875-910. doi:10.1161/CIR.0b013e318256f1e0.</li> <li class="references">Steg G, James SK, Atar D, et al; ESC Committee for Practice Guidelines. ESC guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation [Published online ahead of print August 24, 2012].&nbsp;<em>Eur Heart J.</em>&nbsp;doi:10.1093/eurheartj/ehs215.</li> <li class="references">Guyatt GH, Akl EA, Crowther M, et al; for the American College of Chest Physicians. Executive Summary: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines.&nbsp;<em>Chest.</em>&nbsp;2012;141(suppl 2):7S-47S. doi:10.1378/chest.1412S3.</li> <li class="references">Levine GN, Bates ER, Blankenship JC, et al. 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography Interventions [Published online ahead of print November 7, 2011].&nbsp;<em>J Am Coll Cardiol.</em>&nbsp;doi:10.1016/j.jacc.2011.08.007.</li> <li class="references">Hillis LD, Smith PK, Anderson JL, et al. 2011 ACCF/AHA guideline for coronary artery bypass graft surgery: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines [Published online ahead of print November 7, 2011].&nbsp;<em>J Am Coll Cardiol.</em>doi:10.1016/j.jacc.2011.08.009. </li> </ol> </div> <div class="module-box-alt left az"> <ul class="az"> <li class="title">Study Results and Analysis</li> <li class="img"><a href="/web/20130807085005/http://www.healio.com/cardiology/acute-coronary-syndrome-resource-center/plato-study-results-reviewed"><img src="/web/20130807085005im_/http://www.healio.com/~/media/Images/Resource Centers/AZ ACS RC/study_results_icon.jpg" alt="Plato Trial"/></a></li> <li class="az"><a href="/web/20130807085005/http://www.healio.com/cardiology/acute-coronary-syndrome-resource-center/plato-study-results-reviewed">Study results show reduced rate of CV events in patients presenting with ACS<br/> </a></li> <li class="az-body"><a href="/web/20130807085005/http://www.healio.com/cardiology/acute-coronary-syndrome-resource-center/plato-study-results-reviewed"><span style="color: #61116a;">View a PDF</span> of the journal article on this study, excerpted from the September 10, 2009, issue of the <em>New England Journal of Medicine</em>.<br/> <br/> <em style="font-size: 9px;"></em> </a></li> </ul> <!-- <a class="jump-link az" href="/cardiology/acute-coronary-syndrome-resource-center/plato-study-results-reviewed" originalAttribute="href" originalPath="#" originalAttribute="href" originalPath="/cardiology/acute-coronary-syndrome-resource-center/plato-study-results-reviewed">More <span>&raquo;</span></a>--></div> <div class="module-box-alt right az"> <ul class="az"> <li class="title">Cost Savings Program</li> <li class="img"><a href="/web/20130807085005/http://www.healio.com/cardiology/acute-coronary-syndrome-resource-center/cost-savings-program-assists-patients"><img alt="" src="/web/20130807085005im_/http://www.healio.com/~/media/Images/Resource Centers/AZ ACS RC/azsavingsCardicon.png"/></a></li> <li class="az"><a href="/web/20130807085005/http://www.healio.com/cardiology/acute-coronary-syndrome-resource-center/cost-savings-program-assists-patients">Help Your Patients Save Money<br/> </a></li> <li class="az-body"><a href="/web/20130807085005/http://www.healio.com/cardiology/acute-coronary-syndrome-resource-center/cost-savings-program-assists-patients">Eligible patients receive one month's (up to 60 tablets) prescription free, plus additional monthly savings.*</a></li> </ul> <p style="font-size: 11px;">*Subject to eligibility rules; restrictions apply.</p> <ul class="az"> <li><a href="/web/20130807085005/http://www.healio.com/cardiology/acute-coronary-syndrome-resource-center/cost-savings-program-assists-patients" class="jump-link az">More <span>&raquo;</span></a></li> </ul> </div> </div> <!-- /silo content --> <div class="AZ-Full-Disclaimer"> <h2>IMPORTANT SAFETY INFORMATION ABOUT BRILINTA<br/> <br/> WARNING: BLEEDING RISK</h2> <ul> <li><span><strong>BRILINTA, like other antiplatelet agents, can cause significant, sometimes fatal, bleeding</strong></span></li> <li><span><strong>Do not use BRILINTA in patients with active pathological bleeding or a history of intracranial hemorrhage</strong></span></li> <li><span><strong>Do not start BRILINTA in patients planned to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue BRILINTA at least 5 days prior to any surgery</strong></span></li> <li><span><strong>Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgical procedures in the setting of BRILINTA</strong></span></li> <li><span><strong>If possible, manage bleeding without discontinuing BRILINTA. Stopping BRILINTA increases the risk of subsequent cardiovascular events</strong></span></li> </ul> <h2>WARNING: ASPIRIN DOSE AND BRILINTA EFFECTIVENESS</h2> <ul> <li><span><strong>Maintenance doses of aspirin above 100 mg reduce the effectiveness of BRILINTA and should be avoided. After any initial dose, use with aspirin 75 mg - 100 mg per day</strong></span></li> </ul> <h2>CONTRAINDICATIONS</h2> <ul> <li><span>BRILINTA is contraindicated in patients with a history of intracranial hemorrhage and active pathological bleeding such as peptic ulcer or intracranial hemorrhage. BRILINTA is contraindicated in patients with severe hepatic impairment because of a probable increase in exposure; it has not been studied in these patients. Severe hepatic impairment increases the risk of bleeding because of reduced synthesis of coagulation proteins. BRILINTA is also contraindicated in patients with hypersensitivity (e.g. angioedema) to ticagrelor or any component of the product.</span></li> </ul> <h2>WARNINGS AND PRECAUTIONS</h2> <ul> <li><span>Moderate Hepatic Impairment: Consider the risks and benefits of treatment, noting the probable increase in exposure to ticagrelor</span></li> <li><span>Premature discontinuation increases the risk of MI, stent thrombosis, and death</span></li> <li><span>Dyspnea was reported in 14% of patients treated with BRILINTA and in 8% of patients taking clopidogrel. Dyspnea resulting from BRILINTA is self-limiting. Rule out other causes</span></li> <li><span>BRILINTA is metabolized by CYP3A4/5. Avoid use with strong CYP3A inhibitors and potent CYP3A inducers. Avoid simvastatin and lovastatin doses &gt;40 mg</span></li> <li><span>Monitor digoxin levels with initiation of, or any change in, BRILINTA therapy</span></li> </ul> <h2>ADVERSE REACTIONS</h2> <ul> <li><span>The most commonly observed adverse reactions associated with the use of BRILINTA vs clopidogrel were Total Major Bleeding (11.6% vs 11.2%) and dyspnea (14% vs 8%)</span></li> <li><span>In clinical studies, BRILINTA has been shown to increase the occurrence of Holter-detected bradyarrhythmias. PLATO excluded patients at increased risk of bradycardic events. Consider the risks and benefits of treatment</span></li> </ul> <a name="INDICATIONS" id="INDICATIONS"></a> <h2>INDICATIONS</h2> <p>BRILINTA is indicated to reduce the rate of thrombotic cardiovascular (CV) events in patients with acute coronary syndrome (ACS) (unstable angina, non&ndash;ST-elevation myocardial infarction, or ST-elevation myocardial infarction). BRILINTA has been shown to reduce the rate of a combined end point of CV death, myocardial infarction (MI), or stroke compared to clopidogrel. The difference between treatments was driven by CV death and MI with no difference in stroke. In patients treated with PCI, it also reduces the rate of stent thrombosis.</p> <p>BRILINTA has been studied in ACS in combination with aspirin. Maintenance doses of aspirin &gt;100 mg decreased the effectiveness of BRILINTA. Avoid maintenance doses of aspirin &gt;100 mg daily.</p> <p><span class="fine-purple">Please read accompanying full</span> <a target="_blank" href="https://web.archive.org/web/20130807085005/http://www.astrazeneca-us.com/cgi-bin/az_pi.cgi?product=brilinta&amp;country=us&amp;popup=no" rel="gaeventtracking;AstraZeneca Resource Center;Open Page;Prescribing Information" class="fine-orange">Prescribing Information</a> <img alt="" src="https://web.archive.org/web/20130807085005im_/http://www.brilintatouchpoints.com/images/pdf.gif"/> <img alt="" src="https://web.archive.org/web/20130807085005im_/http://www.brilintatouchpoints.com/images/icon-external.png"/>, <span class="fine-purple">including Boxed WARNINGS, and </span> <a id="clickFullMGLinkInISIFooter" target="_blank" href="https://web.archive.org/web/20130807085005/http://www1.astrazeneca-us.com/pi/brilinta.pdf#page=8" rel="gaeventtracking;AstraZeneca Resource Center;Open Page;Medication Guide" class="fine-orange">Medication Guide</a><img alt="" src="https://web.archive.org/web/20130807085005im_/http://www.brilintatouchpoints.com/images/pdf.gif"/> <img alt="" src="https://web.archive.org/web/20130807085005im_/http://www.brilintatouchpoints.com/images/icon-external.png"/>. </p> <p>You are encouraged to report negative side effects of prescription drugs to the FDA. Visit <a href="https://web.archive.org/web/20130807085005/http://www.fda.gov/medwatch" target="_blank" rel="gaeventtracking;AstraZeneca Resource Center;Open Page;FDA Medwatch" class="fine-orange">www.FDA.gov/medwatch</a> or call 1-800-FDA-1088.</p> <p><a href="https://web.archive.org/web/20130807085005/http://www.brilinta.com/contact-us.aspx" target="_blank" rel="gaeventtracking;AstraZeneca Resource Center;Open Page;Contact Us">Contact Us</a></p> <p style="text-align: right;">2006108 Last updated 03/13</p> </div> <h2></h2> <br/> </div> <div class="social-links"> <ul class="share"> <li><a href="javascript:void(0)" id="email">Email</a></li> <li class="last"><a href="javascript:void(0)" id="print">Print</a></li> </ul> </div> </div> <!-- /main-content --> <!-- sidebar --> <!-- googleoff: index --> <div id="sidebar"> <!-- googleoff: index --> <div class="sidebar-box related" id="az-related"><h5><img alt="" src="/web/20130807085005im_/http://www.healio.com/~/media/Images/Resource Centers/AZ ACS RC/azhealiotinylogo.png"/> Related Content</h5> <p class="head-link"><a href="#">See also Healio / Cardiology <span>&raquo;</span></a></p> <p class="subhead"> Featured Content </p> <!-- item 1 --> <ul> <li class="img"><a href="/web/20130807085005/http://www.healio.com/cardiology/acute-coronary-syndrome-resource-center/the-role-of-bleeding-in-acs-outcomes"><img alt="" src="/web/20130807085005im_/http://www.healio.com/~/media/Images/Resource Centers/AZ ACS RC/Mehran_Roxana.jpg"/></a></li> <li><a href="/web/20130807085005/http://www.healio.com/cardiology/acute-coronary-syndrome-resource-center/the-role-of-bleeding-in-acs-outcomes"><strong>The role of bleeding in ACS outcomes</strong></a></li> <li><em>Roxana Mehran, MD</em></li> <li><a class="jump-link" href="/web/20130807085005/http://www.healio.com/cardiology/acute-coronary-syndrome-resource-center/the-role-of-bleeding-in-acs-outcomes">More <span>&raquo;</span></a></li> </ul> <!-- /item 1 --> <!-- item 2 --> <ul> <li class="horiz"> </li> <li class="no-pic"><strong><a href="/web/20130807085005/http://www.healio.com/cardiology/acute-coronary-syndrome-resource-center/reported-gender-differences-in-acs-a-review-of-recent-studies">Reported gender differences in ACS &ndash; 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